scholarly journals Development and Testing of a Novel Measure to Assess Fidelity of Implementation: Example of the Mini-AFTERc Intervention

2020 ◽  
Vol 11 ◽  
Author(s):  
Nathalie Georgia Brandt ◽  
Calum Thomas McHale ◽  
Gerald Michael Humphris

BackgroundFidelity of implementation (FOI) reflects whether an intervention was implemented in clinical practice according to the originally developed manual and is a key aspect in understanding intervention effectiveness. To illustrate this process of developing a fidelity measure, this study uses the Mini-AFTERc, a brief psychological intervention aimed at managing breast cancer patients’ fear of cancer recurrence, as an example.ObjectivesTo illustrate the development of an FOI measure through (1) applying this process to the Mini-AFTERc intervention, by including the design of a scoring system and rating criteria; (2) content validating the FOI measure using thematic framework analysis as a qualitative approach; (3) testing consistency of the FOI measure using interrater reliability.MethodsThe FOI measure was developed, its scoring system modified and the rating criteria defined. Thematic framework analysis was conducted to content validate the FOI measure using nine intervention discussions between four specialist cancer nurses and four breast cancer patients, and one simulated breast cancer patient. Intraclass-correlation was conducted to assess interrater reliability.ResultsThe qualitative findings suggested that the Mini-AFTERc FOI measure has content validity as it was able to measure all five components of the Mini-AFTERc intervention. The interrater reliability suggested a moderate to excellent degree of reliability among three raters, rICC = 0.84, 95% CI [0.51, 0.96].ConclusionThe study has illustrated the steps that an FOI measure can be developed through a systematic approach applied to the Mini-AFTERc intervention. The FOI measure was found to have content validity and was consistently applied, independently, by three researchers familiar with the Mini-AFTERc intervention. Future studies should determine whether similar levels of interrater reliability can be obtained by distributing written and/or video instructions to researchers who are unfamiliar with the FOI measure, using a larger sample. Employing developed and validated FOI measures such as the one presented for the Mini-AFTERc would facilitate implementation of interventions in the FCR field in clinical practice as intended.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: NCT03763825.

Author(s):  
Marta Gascón Ruiz ◽  
Diego Casas Deza ◽  
Miguel Lafuente Blasco ◽  
Andrea Sesma Goñi ◽  
Mara Cruellas Lapeña ◽  
...  

2018 ◽  
Vol 195 (4) ◽  
pp. 289-296 ◽  
Author(s):  
Paul Rogowski ◽  
Stephan Schönecker ◽  
Montserrat Pazos ◽  
Daniel Reitz ◽  
Michael Braun ◽  
...  

Breast Care ◽  
2016 ◽  
Vol 11 (1) ◽  
pp. 52-56 ◽  
Author(s):  
Ling Wang ◽  
Hui-Ping Li ◽  
An-Nuo Liu ◽  
De-Bin Wang ◽  
Ya-Juan Yang ◽  
...  

Background: Lymphedema (LE) is recognized as a common complication after axillary lymph node dissection (ALND). Numerous studies have attempted to identify risk factors for LE. However, it is difficult to predict the probability of LE for an individual patient. The purpose of this study was to construct a scoring system for predicting the probability of LE after ALND for Chinese breast cancer patients. Patients and Methods: 358 breast cancer patients were surveyed and followed for 12 months. LE was defined by circumferential measurement. Univariate and multivariate logistic regression analyses were used to screen risk factors of LE. Based on this, ß-coefficient of each risk factor was translated into a prognostic score and the scoring system was constructed. The area under the receiver operating characteristic curve (AUC) and calibration were calculated as an index for the predictive value of the scoring system. The model was internally validated using bootstrapping techniques. Results: The incidence rate of LE was 31.84%. Variables associated with LE and their corresponding score in the scoring system were: the level of ALND (level I = 0, level II = 1, level III = 2), history of hypertension (yes = 1, no = 0), surgery on dominant arm (yes = 1, no = 0), radiotherapy (yes = 2, no = 0), and surgical infection/seroma/early edema (yes = 2, no = 0). The probability of LE was predicted according to the total risk scores. The system had good discrimination, with an AUC at 0.877. If a cut-off value of 3 was used, the sensitivity was 81.20% and the specificity was 80.90%. An individual whose total risk score was higher than 3 was recognized as being at risk for LE. On internal validation, the bootstrap-corrected predictive accuracy was 0.798. The model demonstrated excellent calibration in the development set and internal validation. Conclusions: Our scoring system could be a simple and easy tool for physicians to estimate the risk of LE.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18184-e18184
Author(s):  
Lorenzo Gervaso ◽  
Alberto J. Montero ◽  
Xuefei Jia ◽  
Alok A. Khorana

e18184 Background: Venous thromboembolism (VTE) complicates several anti-cancer regimens including chemotherapy and anti-angiogenic agents. Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are a new approach for hormone receptor positive (HR+) metastatic breast cancer (mBC). Reported VTE rates in randomized trials range from 0.6% for ribociclib (MONALEESA-2) to 2% for palbociclib (PALOMA-3) and 5% for abemaciclib (MONARCH-3) but these may underestimate actual rates compared to patients in clinical practice who are generally older and have greater comorbidities. Little is known about real world incidence or prevalence of VTE with CDKIs in mBC. The aim of this study was to evaluate rates of VTE in clinical practice and association with outcomes in mBC patients on CDKIs. Methods: We conducted a retrospective cohort study at Cleveland Clinic Taussig Cancer Institute, approved by the institutional review board. We identified consecutive mBC patients who received any of three FDA-approved CDKIs (palbociclib, ribociclib, abemaciclib) from 1/2015 through 12/2017. VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) were identified by electronic medical record review. Overall survival (OS), progression free survival (PFS) and time to VTE were estimated by the Kaplan-Meier method and evaluated for association with VTE using Cox proportional hazard regression. Results: The study population included 424 patients, with a median age at diagnosis of 54.76 yrs, (range 27 -85). Palbociclib was the most commonly used CDKI (n = 390, 91.8%); 27 patients (6.3%) received more than one drug. VTE during CDKI therapy occurred in 9% of patients (n = 38), including DVT in 52.6% (n = 20), PE in 18.5% (n = 7) and visceral vein thrombosis (VVT) in 15.8% (n = 6). Median time to VTE was 314 days, and 6-months rate was 4.1%. VTE was associated with numerically worse PFS and OS, but this was not statistically significant (PFS [HR 1.25, 95% CI 0.73 – 2.14, p = 0.42], OS [HR 1.60, 95% CI 0.89 – 2.87, p = 0.12]). Conclusions: VTE affected nearly 10% of breast cancer patients receiving CDKIs, 2- to 5-fold greater than reported in registration trials. Further work is necessary to identify pathophysiology, risk factors and benefit of thromboprophylaxis.


2006 ◽  
Vol 32 (10) ◽  
pp. 1170-1174 ◽  
Author(s):  
A.R. Carmichael ◽  
K. Aparanji ◽  
P. Nightingale ◽  
R. Boparai ◽  
P.S. Stonelake

2003 ◽  
Vol 6 (6) ◽  
pp. 731-732
Author(s):  
M Pangali ◽  
A Karokis ◽  
K Gennatas ◽  
P Makrantonakis ◽  
C Markopoulos ◽  
...  

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